Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-03-22 @ 11:06 AM
Study NCT ID:
NCT03828695
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterocervical Angle in Idiopathic Polyhydramnios
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.', 'timeFrame': '6 month', 'description': 'During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Labor']}, 'descriptionModule': {'briefSummary': 'To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor in isolated polyhydramnios'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated polyhydramnios pregnancies\n* no previous systemic illnesses\n\nExclusion Criteria:\n\n* abnormal Pap smear\n* previous cesarean section\n* history of dilatation and curettage (D\\&C)\n* history of loop electrosurgical excision procedure (LEEP) and cervical conization'}, 'identificationModule': {'nctId': 'NCT03828695', 'briefTitle': 'Uterocervical Angle in Idiopathic Polyhydramnios', 'organization': {'class': 'OTHER', 'fullName': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}, 'officialTitle': 'Efficacy and Efficiency of Uterocervical Angle for Prediction of Preterm Labor in Patients With Idiopathic Polyhydramnios: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '10988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'uterocervical angle', 'description': 'uterocervical angle is the angle between lower segment of uterus and cervix', 'interventionNames': ['Other: uterocervical angle']}], 'interventions': [{'name': 'uterocervical angle', 'type': 'OTHER', 'description': 'uterocervical angle is the angle between lower segment of uterus and cervix', 'armGroupLabels': ['uterocervical angle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Nefise N YENIGUL', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nefise Nazlı YENIGUL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Assistant Professor Department of Obstetrics and Gynecology', 'investigatorFullName': 'Nefise Nazlı YENIGUL', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}